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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrafiltration in the home.

All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit with or without a pre-attached high permeability filter. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The System is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility and is also indicated for hemodialysis and/or ultrafiltration in the home.

The provided text is a 510(k) Premarket Notification for the NxStage System One, a hemodialysis system. The submission is primarily to expand the indication for use to include hemodialysis in the home. It is not an AI-powered device, but rather a medical device designed for hemofiltration, hemodialysis, and/or ultrafiltration. Therefore, many of the typical AI/ML-specific questions regarding acceptance criteria and study design are not applicable.

Here's an analysis based on the information provided, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it refers to "parameters used to establish the substantial equivalence" which are:

• Ability to deliver the clinically prescribed amount of therapy.
• Incidence of adverse events.

The reported device performance in relation to these parameters is that the clinical study demonstrated the device's substantial equivalence to the predicate device in terms of "efficacy, accuracy, and safety" for the expanded home use indication.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Thirty-two subjects (ITT population).
• Data Provenance: The document does not specify the country of origin of the data. It states the study was conducted at "six investigational sites," which are implied to be within the scope of the FDA submission, likely in the US, but not explicitly stated. The study was a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a hemodialysis system, not an AI/ML diagnostic tool that relies on expert interpretation for ground truth establishment. The "ground truth" in this context would be the actual clinical outcomes and the ability of the device to perform its intended physiological function, which are measured directly.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation or similar diagnostic tasks where human expert consensus is required. For a medical device like a hemodialysis system, the performance is assessed through direct measurement of therapy delivery and observation of adverse events, not through expert adjudication of diagnostic findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The NxStage System One is a medical device, not an AI system. Therefore, there is no concept of comparing human readers with and without AI assistance for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The NxStage System One is a device that requires human interaction (prescription, observation by a trained person) and is not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this study, implicitly, would be:

• Outcomes data: The ability of the device to deliver the "clinically prescribed amount of therapy." This refers to the physiological effect and measurement of dialysis parameters.
• Adverse events: The actual occurrence or non-occurrence of adverse events, observed and recorded during the study.

The study design used a "each patient serving as his or her own control" methodology, comparing home environment use to in-center environment use.

8. The sample size for the training set

This is not applicable. The NxStage System One is not an AI/ML device, and thus does not have a "training set" in the context of machine learning. The clinical study described is for validation to expand indications, not for training a model.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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